FDA Expected to Issue Final DSCSA Rule Governing Distributors and 3PLs
by Maureen Perroni, on June 24, 2016
When the Drug Supply Chain Security Act was signed into law in 2013, the U.S. Food and Drug Administration was granted two years to write and issue rules regarding the licensing of prescription drug wholesale distributors and third-party logistics providers, otherwise known as "3PLs". Though the initial deadline of November 2015 has long since passed, the FDA now appears ready to issue its regulations by December of this year, as indicated by the upcoming Department of Health and Human Services regulatory agenda.
The DSCSA establishes industry-wide standards for tracking and traceability of pharmaceuticals. The law's purpose is to make the manufacturing and sale of pharmaceutical drugs safer, and one of the more groundbreaking moves that the government made in passing it was to define the role that 3PLs occupy within the supply chain. Though they may possess products, 3PLs do not legally own them, which changes the types of record-keeping requirements to which they must adhere.
In the absence of clear federal rules, however, some 3PLs have been left in limbo. As noted by an article on Monday, the law requires 3PLs to be licensed by either the FDA or states that have their own separate licensing agreements. Since this is not true of all states, the 3PLs located there do not have a clear path forward. This, in turn, places added pressure on pharmaceutical manufacturers. If they are going to send their products through the supply chain to market, they need to have a clear view of which labeling requirements will be expected of them and which burdens will fall to other players.
The expected action by the FDA should clear up many issues that have remained in the wake of the DSCSA's passage. This will clear the way for the pharmaceutical industry to comply with new traceability requirements with the help of an Enterprise Labeling Solution.
To find out how Ferring Pharmaceutical leveraged enterprise labeling best practices to optimize global labeling and maximize its investment in its WMS applications, download the on-demand webinar today.